Tag: Life Sciences commercial requirements

There is no question there are many system considerations when it comes to preparing your company to go commercial – each of which will depend on the business model you have and what business processes will be maintained in-house versus what is outsourced. Such considerations might depend on whether manufacturing and fulfillment would be internal or through both a contract manufacturer and 3PL. Other considerations include the following:

System of Record: Do you want your ERP software system to be the ‘system of record’ where you’ll be able to defend full product traceability in this system for FDA purposes. Or, will this traceabilty be paper-based?

3PL Integration / Contract Manufacturer Integration: Is your 3rd party logistics provider able to provide data integrations communications of product that was shipped. How about providing your manufacturer with visibility into sales demand, and you with visibility into finished product or product costing?

Serial / Lot Controlled Items: Unless you’ve passed off all inventory responsibility to a contract manufacturing and 3PL, you’ll need full product lot or serial traceability and a means for managing this added element of effort.

CRM Requirements: Do you have plans for a CRM system, or the ability for the sales team to easily manage leads, opportunities and prospective client communications and follow ups so that new business doesn’t fall through the cracks?

Quality Management: Once sales of product occurs, it important to have strict controls over the inbound product quality and quality control through the manufacturing process. Only specialized systems can manage these quality considerations.

Material Planning: Making sure the right products are available for the forecasted sales activity can become very important for some companies, which means they need to put an MRP and Sales Forecasting system in place to balance supply and demand.

Online Ordering / eCommerce: Today’s customer requires much more flexibility into how and when orders are placed for your product in the market. However, online ordering comes with many complex challenges especially when dealing with FDA controlled products and operations.

Expense Management: Once there is a sales team selling product, there are regulations in place for how they communicate with potential clients and how they can spend money on them. One of those requirements is outlined in the ‘Sunshine Act’. Make sure the systems help you managed towards these regulations.

If you would like to discuss these system considerations in more detail, or would like an assessment done of your current system, please contact Tridea Partners: sales@trideapartners.com.